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Cimzia

New Phase 3 data confirms safety and efficacy of UCB's Cimzia in plaque and psoriatic arthritis

New Phase 3 data has been released by UCB Pharma on the safety of Cimzia (certolizumab pegol) in the treatment of moderate-to-severe plaque psoriasis, and its efficacy in patients showing signs of psoriasis-related nail disease and those showed an inadequate early treatment response to the drug.

The first 96 weeks of data derived from 995 participants across two ongoing Phase 3 studies demonstrated that “confirmed the long-term safety of Cimzia in the treatment of psoriasis”, with no new safety concerns flagged, while the overall incidence of adverse events was low.

NICE recommends UCB's Cimzia in severe plaque psoriasis

NICE has announced its decision to recommend UCB Pharma’s Cimzia (certolizumab pegol) for use on the NHS in England in the treatment of severe plaque psoriasis in patients who have failed to respond to, or are unsuitable for, other systemic treatments.

The judgement also adds an additional treatment option for women before or during pregnancy, as well as while breastfeeding.

NICE approves Cimzia but blocks Ilumetri in treatment of psoriasis

UK drug watchdog NICE has announced two new recommendations relating to medicines for the treatment of psoriasis, approving UCB Pharma’s Cimzia (certolizumab pegol) for use on the NHS, but rejecting Almirall’s Ilumetri (tildrakizumab).

The organisation chose to recommend Cimzia for the treatment of severe plaque psoriasis in adult patients that have proven unresponsive to other systemic treatments such as phototherapy, methotrexate and ciclosporin, or if these treatments are not found to be unsuitable.

EMA approves Cimzia for use in treating plaque psoriasis

The Brussels-based pharmaceutical company UCB has announced that the European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol), to include a new indication in adult patients with moderate-to-severe plaque psoriasis.

The approval of the monoclonal antibody signals the multinational company’s entry into immune-dermatology. With an estimated 3% of the population or approximately 125 million people suffering from psoriasis across the globe, the disease area is one in which significant unmet need exists.

UCB's Cimzia secures first-of-its-kind FDA approval in plaque psoriasis

The FDA has expanded the label for UCB’s Cimzia (certolizumab pegol) in the US, approving the therapy for the treatment of moderate-to-severe plaque psoriasis in adult patients eligible for systemic therapy or phototherapy, it has emerged.

Nice backs UCB’s Cimzia as alternate therapy for severe rheumatoid arthritis

The National Institute for Health and Care Excellence (Nice) has recommended UCB Pharma’s Cimzia (certolizumab pegol) on its own or in combination with methotrexate, to treat rheumatoid arthritis when other drugs haven’t worked or aren’t suitable.

The regulator already recommends Cimzia for treating severe rheumatoid arthritis which has not responded to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs (DMARDs).

New UCB chief starts and expands team

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New UCB chief executive Jean-Christophe Tellier who succeeded Roch Doliveux this year has also welcomed three new members to the Belgium biopharma firm.

As announced in 2014 Tellier, who is also its chairman, replaced Doliveux in the top job after he stepped down on 31 December after leading UCB for the last 10 years. Its board of directors granted Doliveux the titles of honorary member of the board and honorary chairman of the executive committee.

Biotech industry failed by UK, says UCB

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The UK biotechnology industry has ‘missed the boat’ and not fulfilled its potential, according to outgoing UCB chief executive Roch Doliveux.

Speaking to journalists at the announcement of UCB’s financial results for 2013, Doliveux said that the UK had failed to “transform [its] biotechs and its fantastic science into sustainable, mid-sized companies”. 

Cimzia results excite UCB in psoriatic arthritis

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UCB will submit Cimzia for psoriatic arthritis by the end of 2012, after positive Phase III trial results for the drug.

Results from the Cimzia study showed that patients with adult onset active psoriatic arthritis had a statistically significant improvement at week 12, in the signs and symptoms of psoriatic arthritis.

The anti-TNF drug is already approved in a number of markets for rheumatoid arthritis and Crohn’s disease, and made the firm €198 million in 2010.

UCB plans €250m plant to meet Cimzia demand

Belgian biotechnology company UCB has started construction of a new microbial manufacturing facility in Bulle, Switzerland to help meet demand for its rheumatoid arthritis and Crohn's disease treatment Cimzia.

The company said that the new production plant is expected to be operational in 2015 and will require an investment of 250 million euros in two phases.

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